Samer K. Khaled, M.D. – FDA EIR, Dec 23, 2020

An FDA inspection of Samer K. Khaled, M.D., located in Duarte, CA, was conducted from December 17-23, 2020. This comprehensive inspection, performed under the Bioresearch Monitoring Compliance Program for Clinical Investigators, focused on Good Clinical Practices (GCPs) in support of a PDUFA application. The primary violation identified was a "Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation." Specifically, one serious adverse event (SAE) and three other adverse events (AEs) were not reported in a timely manner, with some only identified after discovery by study monitors, indicating an over-reliance on monitors for critical safety reporting. Further issues included incomplete SAE report forms, delays in the investigator’s sign-off on SAE reports, and insufficient documentation of investigational product administration times. These findings mirrored observations from a prior FDA inspection in January 2019. Dr. Khaled received an FDA Form 483 – Inspectional Observations and was reminded of the legal implications under the Food Drug and Cosmetic Act. The site is required to submit a comprehensive response to the FDA 483 within 15 business days. The Agency will determine if the observations constitute violations, underscoring the necessity for complete and accurate reporting of all adverse events and adherence to study protocols to ensure patient safety and data integrity.